FDA Device Recall Z-0471-2022: Philips North America Llc

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0471-2022.

Recall Res Number

Z-0471-2022

Recalling Firm / Manufacturer

Philips North America Llc

FEI Number

3016618143

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2021-11-12

Date Posted

N/A

Date Terminated

2024-02-05

Product Code

OWB

Event Number

89174

Product Quantity

10 units (1 US and 9 OUS)

Product Description Philips Azurion Interventional Fluoroscopic X-ray System with Azurion R2.2 with LUC configuration start-up issue; Azurion R2.2 emergency stop recovery issue Model Numbers: 722221, 722228, 722225, 722068, 722226, 722078, 722224

Reason for Recall (1)Start-up problem: Intermittently at start-up of the system, the communication of the control unit that manages the movement of the stand is not established; (2) Emergency stop recovery problem-warm restart is not executed correctly and movement functionality is not available

Action Details Philips issued Field Safety Notice on 11/12/21 U.S.A, Customer notified via certified mailing from the United States Postal Service (USPS). Letters outside of the U.S.A. will be distributed through the Philips Markets Organization. Letter states reason for recall, health risk and action to take: Start-up problem: If the start-up problem occurs, perform a Cold Restart* of the system. b) Emergency stop recovery problem: If the emergency stop recovery problem occurs, perform a new Warm Restart* of the system. c) Place this Field Safety Notice with the documentation of the system until Philips has installed a software update in your system. d) Circulate this notice to all users of this device so they are aware of the product issues. e) Return the attached reply form to Philips to confirm that the users of the system have reviewed and understood this Field Safety Notice. * The system restart options are described in section 4.2 of the Instructions for Use. 5. Describe the actions planned by Philips IGT Systems to correct these problems: These problems will be resolved by a software update (available in November 2021). You will be contacted by your local Philips representative to schedule the update of your system. If you need any further information, please contact your local Philips representative (reference to FC072200502).

Distribution Pattern Worldwide distribution - US Nationwide distribution in the state of WA and the countries of France, Germany, Japan, Poland, United Kingdom.

Code Information / Serial Numbers US: Model 722068 Azurion 7 B20 S/N: 109 UDI: (01)00884838085367(21)109. OUS: Model: S/N UDI: 722226 Azurion 7 B20 176 (01)00884838099272(21)176; 722228 Azurion 5 M20 3 (01)00884838099234(21)3; 722221 Azurion 3 M12 8 (01)00884838099203(21)8; 722225 Azurion 7 B12 16 (01)00884838099265(21)16; 722225 Azurion 7 B12 73 (01)00884838099265(21)73; 722226 Azurion 7 B20 42 (01)00884838099272(21)42; 722226 Azurion 7 B20 157 (01)00884838099272(21)157; 722224 Azurion 7 M20 293 (01)00884838099258(21)293; 722078 Azurion 7 M12 220 (01)00884838085251(21)220

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Medical Device Recall: Z-0471-2022

Recall Parameters & Description

Related Establishments / Registrations

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